FDA.reportPublic FDA data

MiniMed® 530G

Primary DI
00643169507135
Brand
MiniMed® 530G
Company
MEDTRONIC MINIMED, INC.
Model
MMT-751LNAL
Device description
PUMP MMT-751LNAL PRDGM V3.0 CL EN PR LN
Published
2014-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OZOArtificial pancreas device system, threshold suspend

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZOAutomated Insulin Dosing , Threshold SuspendUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P120010005

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P120010005MINIMED 530G SYSTEMMedtronic, Inc.2013-09-26OZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169507135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169507135006431695071356431695071350643169507135

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump, electronicA portable, battery-powered, electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus. It may be badge-like, designed to adhere to skin or clothing (e.g., with a pressure-sensitive adhesive), or worn in a case attached to the belt or carried in a pocket. It includes a reservoir (e.g., a cartridge similar to a syringe), a pumping mechanism, and an infusion-rate controller. The pump infuses microvolume pulses and/or bolus doses of insulin subcutaneously, typically into the abdomen, through a needle or catheter (not included).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
849626338
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150002375MiniMed AppMMT-80982026-05-25
00199150002382MiniMed AppMMT-80992026-05-25
00199150077380MiniMed FlexMMT-80622026-05-25
00199150021031MiniMed FlexMMT-80702026-05-24
00763000848149MiniMed FlexMMT-80622026-05-21
00763000848156MiniMed FlexMMT-80722026-05-21
00763000990695INFINITY™ Occipitocervical Upper Thoracic System36503152026-03-22
20763000519692Guardian™ 4 SensorMMT-7040MA2023-05-06
20763000413389Guardian™ 4 SensorMMT-7040A2023-05-06
00763000413477Guardian™ 4 SensorMMT-7040B2023-05-05
20763000519685Guardian™ 4 SensorMMT-7040PA2023-05-06
20763000273358MiniMed™ ReservoirMMT-332A2019-09-02
00199150047000MiniMed 780G Insulin PumpMMT-18842025-11-08
00199150047024MiniMed 780G Insulin PumpMMT-18842025-11-08
00199150047048MiniMed 780G Insulin pumpMMT-18942025-11-08
00199150047055MiniMed 780G Insulin PumpMMT-1894MD2025-11-08
00199150034123SFTWR MMT-6101 AHCL APP 3.1 ANDROIDMMT-61012025-09-26
00199150034130MiniMed Mobile AppMMT-61022025-09-26
00613994757197iPro™2MMT-77412014-09-25
00613994951274iPro™2MMT-77422014-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169455535ENLiTE™MEDTRONIC MINIMED, INC.OZO2023-07-20
00763000391041Guardian™ Link (3)MEDTRONIC XOMED, INC.OZO2020-10-26
00763000391065Guardian™ Link (3)MEDTRONIC MINIMED, INC.OZO2020-10-26
00763000389024Guardian ™ Link (3)MEDTRONIC XOMED, INC.OZO2020-09-06
00763000400620Guardian™ Link (3)MEDTRONIC MINIMED, INC.OZO2020-09-06
00763000337049Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.OZO2020-07-11
20763000337005Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.OZO2020-07-10
00763000337001Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.OZO2020-07-10
00763000395858MiniMed® 670GMEDTRONIC MINIMED, INC.OZO2020-07-06
00763000367091MiniMed™ 630GMEDTRONIC MINIMED, INC.OZO2020-05-18
00763000341923One-press SerterMEDTRONIC MINIMED, INC.OZO2020-05-16
00763000367053MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2020-05-16
00763000367060MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2020-05-16
00850006613373t:slim X2 Insulin Pump with Basal-IQTandem Diabetes Care, Inc.OZO2020-02-04
00850006613380t:slim X2 Insulin Pump with Basal-IQTandem Diabetes Care, Inc.OZO2020-02-04
00763000317591MiniMed™ 630GMEDTRONIC MINIMED, INC.OZO2019-11-15
00763000317607MiniMed™ 630GMEDTRONIC MINIMED, INC.OZO2019-11-15
00763000317614MiniMed™ 630GMEDTRONIC MINIMED, INC.OZO2019-11-15
00763000317621MiniMed™ 630GMEDTRONIC MINIMED, INC.OZO2019-11-15
00763000316631MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-10-27
00763000316648MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-10-27
00763000316655MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-10-27
00763000316662MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-10-27
00763000316679MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-10-27
00763000316686MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-10-27
10301937550154CONTOUR®NEXTASCENSIA DIABETES CARE US INC.OZO2019-08-30
00763000283445MiniMed® 670GMEDTRONIC MINIMED, INC.OZO2019-08-29
00763000256807MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-05-25
00763000256814MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-05-25
00763000256838MiniMed® 670GMEDTRONIC MINIMED, INC.OZO2019-05-25